Botulinum Toxins, Type A, Muscle Strength
Conditions
Brief summary
The purpose of this feasibility study is to determine if temporary weakness of a small foot muscle caused by local injection of botulinum toxin into that muscle can be measured with a strain gauge in addition to the previously known valid measurements via nerve conduction studies and surface electromyogram.
Detailed description
Purpose/Hypothesis: Verify the validity and reliability of strain gauge assessment of strength of extensor digitorum brevis (EDB) muscle compared to compound muscle action potential (CMAP) size from EDB and surface electromyography (SEMG) data from EDB after injection of botulinum toxin into EDB 1. Primary Outcome Measure: Change in measured strength (using strain gauges) of dorsiflexion of digits 3 and 4 (strength of EDB) after vs. before botulinum toxin injection into EDB 2. Secondary Outcome Measures: 1. Change in CMAP (with standard reference electrode location and with an inactive reference electrode location) from EDB after vs. before botulinum toxin injection into EDB; 2. Change in SEMG parameters from EDB, tibialis anterior (TA), and extensor digitorum longus (EDL) after vs. before botulinum toxin injection into EDB STUDY DESIGN: 1. Overview: Single intramuscular injection of botulinum toxin or placebo (placebo or BOTOX 2 units or BOTOX 20 units, each with a total volume of 0.1 ml) intramuscular into right EDB on Day 0. Strain gauge data and SEMG data from TA and EDL are obtained at each evaluation time: Baseline (3 separate times prior to Day 0 after at least 5 separate training sessions for the strain gauges); Day 1; Day 2; Day 4 (during anticipated rapid change); Day 14 (+/-1 day) (at clinical nadir); Day 21 (+/-1 day) (another day at clinical nadir); and Month 4 (when clinical recovery from the effect of BOTOX should have occurred); CMAP & SEMG data from EDB are obtained at Baseline; Day 4 (close to nadir of CAMP); Day 14 (at nadir of CAMP) and/or Day 21 (at nadir of CAMP); and Month 4 (when clinical recovery from the effect of BOTOX should have occurred but CMAP should not have recovered). 2. Protocol: Single-center, Double-Blind, Randomized, Pilot Trial Total Sample Size: 12-15 Treatment Groups: BOTOX Single Dose 20 units IM in EDB in 0.1 ml BOTOX Single Dose 2 units IM in EDB in 0.1 ml Placebo (Saline) Single Dose IM in EDB in 0.1 ml Estimated Time to Enroll: 0-3 months Estimated Study Duration: 4-6 months
Interventions
20 units, single dose, intramuscular in right EDB muscle
DRUGSaline
Single Dose, Intramuscular into right EDB muscle
Sponsors
Allergan
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal, healthy, male or female subjects, 18 to 54 years of age. * Written informed consent has been obtained. * Females with child-bearing potential have a negative urine pregnancy test and agree to use a reliable form of contraception during the study. * Ability to follow study instructions and likely to complete all required visits. * Written authorization for Use and Release of Health and Research Study Information has been obtained.
Exclusion criteria
* Abnormality by focused history and examination including the presence of foot deformity. * Abnormal (as determined by the investigator) screening nerve conduction studies of the lower limbs. * Identification of anomalous innervation of right EDB via screening nerve conduction studies. * The subject having a foot which does not adequately fit in the modified ankle-foot orthosis used with the strain gauge. * The subject having a foot in which anatomic bone landmarks cannot be adequately identified. * Body mass index (BMI) greater than 30. * History of significant (as determined by the investigator) lower limb injury or lower limb surgery * Any uncontrolled clinically significant medical condition. * Known allergy or sensitivity to any of the components in the study medication. * Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study. * Concurrent participation in another investigational drug or device study or participation within 3 months prior to study. * Treatment with botulinum toxin of any serotype prior to enrollment in study or prior clinical botulism. * Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function. * Evidence of alcohol abuse, drug abuse, or other relevant neuropsychiatric condition. * Infection or skin disorder at an anticipated injection site. * Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results (e.g. variable strength on serial testing during screening examination; or foot, toe, or ankle pain that may limit full participation in muscle strength testing), or interfere significantly with the subject's participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Baseline (3 times) then following single injection of botulinum toxin into EDB with testing at Day 1, Day 2, Day 4, Day 14, Day 21, and Month 4 | The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A) or placebo. The baseline value was the mean of the 3 values for force obtained prior to injection of BoNT/A. The baseline was compared with the subsequent values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Force From Day 14 to Day 21 | Force measured at Day 14 after BoNT/A injction into EDB and Force measured at Day 21 after BoNT/A injction into EDB. | The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A). The force at each day of testing was the mean of the 3 values for force obtained on that day. Value is percent change from baseline. Comparison is made between the percent change from baseline force and the force on Day 14 in each group vs. the percent change from baseline force and the force on Day 21 in each group. |
| Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin) | At each visit for nerve conduction studies following injection of onabotulinumtoxinA (botulinum type A neurotoxin) into EDB (Day 0; Day 4; Day 14; Month 4) | — |
| Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Baseline (mean of 3 measurement on the same day of testing) then following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 | Measure the percent change of the Surface Electromyogram (SEMG) as measured by the Mean Rectified Voltage (MRV) with a window of 500 ms from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A or placebo. Each MRV represents the mean of 3 individual measurements of the MRV at that timepoint with measurements at least 60 seconds apart. In order to facilitate comparison from one subject to the next, the MRV is then converted into percent change from baseline for that subject. |
| Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Stability of Baseline Measurements of Force | Baseline 1 (mean of 3 measurement on the same day of testing) compared with Baseline 2 (mean of 3 measurement on the same day of testing) on a second day compared with Baseline 3 (mean of 3 measurement on the same day of testing) | The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge on three different days prior to injection of BoNT/A or placebo. On each of the three days of baseline testing, the force was defined as the mean of three different measurements, separated by at least 1 minute from another measurement. |
| Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
| Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement | Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A, 20 Units Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units
Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle | 5 |
| Botulinum Toxin, Type A, 2 Units Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units
Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle | 4 |
| Placebo Saline, Single dose, Intramuscular injection into right EDB
Saline: Single Dose, Intramuscular into right EDB muscle | 4 |
| Total | 13 |
Baseline characteristics
| Characteristic | Botulinum Toxin, Type A, 2 Units | Placebo | Botulinum Toxin Type A, 20 Units | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 5 Participants | 13 Participants |
| Age, Continuous | 26.8 years STANDARD_DEVIATION 2.1 | 29.5 years STANDARD_DEVIATION 2 | 31 years STANDARD_DEVIATION 5.9 | 29.2 years STANDARD_DEVIATION 2.3 |
| Region of Enrollment United States | 4 participants | 4 participants | 5 participants | 13 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 5 | 1 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB
The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A) or placebo. The baseline value was the mean of the 3 values for force obtained prior to injection of BoNT/A. The baseline was compared with the subsequent values.
Time frame: Baseline (3 times) then following single injection of botulinum toxin into EDB with testing at Day 1, Day 2, Day 4, Day 14, Day 21, and Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 1 | 7.85 kg | Standard Deviation 3.76 |
| Botulinum Toxin Type A, 20 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 14 | 7.89 kg | Standard Deviation 3.7 |
| Botulinum Toxin Type A, 20 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 4 | 10.42 kg | Standard Deviation 6.56 |
| Botulinum Toxin Type A, 20 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Baseline | 7.63 kg | Standard Deviation 3.31 |
| Botulinum Toxin Type A, 20 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Month 4 | 7.62 kg | Standard Deviation 4.44 |
| Botulinum Toxin Type A, 20 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 21 | 9.60 kg | Standard Deviation 4.51 |
| Botulinum Toxin Type A, 20 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 2 | 9.37 kg | Standard Deviation 3.21 |
| Botulinum Toxin, Type A, 2 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 4 | 4.85 kg | Standard Deviation 0.75 |
| Botulinum Toxin, Type A, 2 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Baseline | 5.16 kg | Standard Deviation 1.48 |
| Botulinum Toxin, Type A, 2 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 1 | 4.28 kg | Standard Deviation 1.02 |
| Botulinum Toxin, Type A, 2 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 2 | 4.46 kg | Standard Deviation 1.22 |
| Botulinum Toxin, Type A, 2 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 14 | 4.75 kg | Standard Deviation 1 |
| Botulinum Toxin, Type A, 2 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 21 | 4.20 kg | Standard Deviation 2.11 |
| Botulinum Toxin, Type A, 2 Units | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Month 4 | 5.27 kg | Standard Deviation 1.37 |
| Placebo | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 14 | 13.46 kg | Standard Deviation 8.49 |
| Placebo | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 1 | 12.22 kg | Standard Deviation 8.26 |
| Placebo | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Month 4 | 11.23 kg | Standard Deviation 6.92 |
| Placebo | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 21 | 11.88 kg | Standard Deviation 6.82 |
| Placebo | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 4 | 11.38 kg | Standard Deviation 9.59 |
| Placebo | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Day 2 | 10.88 kg | Standard Deviation 7.21 |
| Placebo | Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB | Baseline | 10.43 kg | Standard Deviation 5.33 |
Comparison: Two sample t-test comparing baseline and day 1 H0: There is no change in mean force between baseline and day 1 HA: There is change in mean force between baseline and day 1p-value: 0.61t-test, 2 sided
Comparison: Two sample t-test comparing baseline and day 2 H0: There is no change in mean force between baseline and day 2 HA: There is change in mean force between baseline and day 2p-value: 0.787t-test, 2 sided
Comparison: Two sample t-test comparing baseline and day 4 H0: There is no change in mean force between baseline and day 4 HA: There is change in mean force between baseline and day 4p-value: 0.234t-test, 2 sided
Comparison: Two sample t-test comparing baseline and day 14 H0: There is no change in mean force between baseline and day 14 HA: There is change in mean force between baseline and day 14p-value: 0.256t-test, 2 sided
Comparison: Two sample t-test comparing baseline and day 21 H0: There is no change in mean force between baseline and day 21 HA: There is change in mean force between baseline and day 21p-value: 0.292t-test, 2 sided
Comparison: Two sample t-test comparing baseline and month 4 H0: There is no change in mean force between baseline and month 4 HA: There is change in mean force between baseline and month 4p-value: 0.589t-test, 2 sided
Secondary
Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Day 4 | -67.37 percent change from baseline | Standard Deviation 29.18 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Day 14 | -74.00 percent change from baseline | Standard Deviation 24.46 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Month 4 | -52.40 percent change from baseline | Standard Deviation 33.13 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Day 4 | -40.92 percent change from baseline | Standard Deviation 18.9 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Day 14 | -51.03 percent change from baseline | Standard Deviation 26.56 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Month 4 | -37.86 percent change from baseline | Standard Deviation 9.45 |
Comparison: Day 4p-value: <0.0001Spearman Correlation Test
Comparison: Day 14p-value: 0.0374Spearman Correlation Test
Comparison: Month 4p-value: 0.391Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Day 4 | 67.37 percent change from baseline | Standard Deviation 29.18 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Day 14 | -74.00 percent change from baseline | Standard Deviation 24.46 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Month 4 | -52.40 percent change from baseline | Standard Deviation 33.13 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Day 4 | -37.35 percent change from baseline | Standard Deviation 21.98 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Day 14 | -49.49 percent change from baseline | Standard Deviation 28.49 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Month 4 | -38.44 percent change from baseline | Standard Deviation 9.32 |
Comparison: Day 4p-value: <0.0001Spearman Correlation Test
Comparison: Day 14p-value: 0.0374Spearman Correlation Test
Comparison: Month 4p-value: 0.505Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Day 4 | -67.37 percent change from baseline | Standard Deviation 29.18 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Day 14 | -74.00 percent change from baseline | Standard Deviation 24.46 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Month 4 | -52.40 percent change from baseline | Standard Deviation 33.13 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Day 4 | -40.44 percent change from baseline | Standard Deviation 20 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Day 14 | -50.72 percent change from baseline | Standard Deviation 27.4 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Month 4 | -39.22 percent change from baseline | Standard Deviation 9.42 |
Comparison: Day 4p-value: <0.0001Spearman Correlation Test
Comparison: Day 14p-value: 0.0374Spearman Correlation Test
Comparison: Month 4p-value: 0.0374Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Day 4 | -67.37 percent change from baseline | Standard Deviation 29.18 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Day 14 | -74.00 percent change from baseline | Standard Deviation 24.46 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Month 4 | -52.40 percent change from baseline | Standard Deviation 33.13 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Day 4 | -42.43 percent change from baseline | Standard Deviation 19.82 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Day 14 | -52.35 percent change from baseline | Standard Deviation 27.17 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Month 4 | -39.76 percent change from baseline | Standard Deviation 11.26 |
Comparison: Day 4p-value: <0.0001Spearman Correlation Test
Comparison: Day 14p-value: 0.0374Spearman Correlation Test
Comparison: Month 4p-value: 0.104Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Day 4 | -67.37 percent change from baseline | Standard Deviation 29.18 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Day 14 | -74.00 percent change from baseline | Standard Deviation 24.46 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Month 4 | -52.40 percent change from baseline | Standard Deviation 33.13 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Day 4 | -39.89 percent change from baseline | Standard Deviation 22.65 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Day 14 | -51.75 percent change from baseline | Standard Deviation 28.52 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Month 4 | -39.90 percent change from baseline | Standard Deviation 12.43 |
Comparison: Day 4p-value: <0.0001Spearman Correlation Test
Comparison: Day 14p-value: 0.0374Spearman Correlation Test
Comparison: Month 4p-value: 0.188Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Day 4 | -67.37 percent change from baseline | Standard Deviation 29.18 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Day 14 | -74.00 percent change from baseline | Standard Deviation 24.46 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Month 4 | -52.40 percent change from baseline | Standard Deviation 33.13 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Day 4 | -42.09 percent change from baseline | Standard Deviation 21.19 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Day 14 | -51.94 percent change from baseline | Standard Deviation 28.01 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Month 4 | -40.67 percent change from baseline | Standard Deviation 11.48 |
Comparison: Day 4p-value: <0.0001Spearman Correlation Test
Comparison: Day 14p-value: 0.0374Spearman Correlation Test
Comparison: Month 4p-value: 0.0374Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Day 4 | -53.81 percent change from baseline | Standard Deviation 21.81 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Day 14 | -63.78 percent change from baseline | Standard Deviation 21.77 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Month 4 | -48.38 percent change from baseline | Standard Deviation 26.16 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Day 4 | -40.92 percent change from baseline | Standard Deviation 18.9 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Day 14 | -51.03 percent change from baseline | Standard Deviation 26.56 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window). | Month 4 | -37.86 percent change from baseline | Standard Deviation 9.45 |
Comparison: Day 4p-value: 0.0374Spearman Correlation Test
Comparison: Day 14p-value: 0.188Spearman Correlation Test
Comparison: Month 4p-value: 0.391Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Day 4 | -53.81 percent change from baseline | Standard Deviation 21.81 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Day 14 | -63.78 percent change from baseline | Standard Deviation 21.77 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Month 4 | -48.38 percent change from baseline | Standard Deviation 26.16 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Day 4 | -37.35 percent change from baseline | Standard Deviation 21.98 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Day 14 | -49.49 percent change from baseline | Standard Deviation 28.49 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window). | Month 4 | -38.44 percent change from baseline | Standard Deviation 9.32 |
Comparison: Day 4p-value: 0.0374Spearman Correlation Test
Comparison: Day 14p-value: 0.188Spearman Correlation Test
Comparison: Month 4p-value: 0.505Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Day 4 | -53.81 percent change from baseline | Standard Deviation 21.81 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Day 14 | -63.78 percent change from baseline | Standard Deviation 21.77 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Month 4 | -48.38 percent change from baseline | Standard Deviation 26.16 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Day 4 | -40.44 percent change from baseline | Standard Deviation 20 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Day 14 | -50.72 percent change from baseline | Standard Deviation 27.4 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window). | Month 4 | -39.22 percent change from baseline | Standard Deviation 9.42 |
Comparison: Day 4p-value: 0.0374Spearman Correlation Test
Comparison: Day 14p-value: 0.188Spearman Correlation Test
Comparison: Month 4p-value: 0.0374Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Day 4 | -53.81 percent change from baseline | Standard Deviation 21.81 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Day 14 | -63.78 percent change from baseline | Standard Deviation 21.77 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Month 4 | -48.38 percent change from baseline | Standard Deviation 26.16 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Day 4 | -42.43 percent change from baseline | Standard Deviation 19.82 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Day 14 | -52.35 percent change from baseline | Standard Deviation 27.17 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window). | Month 4 | -39.76 percent change from baseline | Standard Deviation 11.26 |
Comparison: Day 4p-value: 0.0374Spearman Correlation Test
Comparison: Day 14p-value: 0.188Spearman Correlation Test
Comparison: Month 4p-value: 0.104Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Day 4 | -53.81 percent change from baseline | Standard Deviation 21.81 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Day 14 | -63.78 percent change from baseline | Standard Deviation 21.77 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Month 4 | -48.38 percent change from baseline | Standard Deviation 26.16 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Day 14 | -51.75 percent change from baseline | Standard Deviation 28.52 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Month 4 | -39.90 percent change from baseline | Standard Deviation 12.43 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window). | Day 4 | -39.89 percent change from baseline | Standard Deviation 22.65 |
Comparison: Day 4p-value: 0.0374Spearman Correlation Test
Comparison: Day 14p-value: 0.188Spearman Correlation Test
Comparison: Month 4p-value: 0.188Spearman Correlation Test
Secondary
Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window).
Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.
Time frame: Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement
Population: Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Month 4 | -48.38 percent change from baseline | Standard Deviation 26.16 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Day 4 | -53.81 percent change from baseline | Standard Deviation 21.81 |
| Botulinum Toxin Type A, 20 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Day 14 | -63.78 percent change from baseline | Standard Deviation 21.77 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Month 4 | -40.67 percent change from baseline | Standard Deviation 11.48 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Day 4 | -42.09 percent change from baseline | Standard Deviation 21.19 |
| Botulinum Toxin, Type A, 2 Units | Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window). | Day 14 | -51.94 percent change from baseline | Standard Deviation 28.01 |
Comparison: Day 4p-value: 0.0374Spearman Correlation Test
Comparison: Day 14p-value: 0.188Spearman Correlation Test
Comparison: Month 4p-value: 0.0374Spearman Correlation Test
Secondary
Difference in Force From Day 14 to Day 21
The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A). The force at each day of testing was the mean of the 3 values for force obtained on that day. Value is percent change from baseline. Comparison is made between the percent change from baseline force and the force on Day 14 in each group vs. the percent change from baseline force and the force on Day 21 in each group.
Time frame: Force measured at Day 14 after BoNT/A injction into EDB and Force measured at Day 21 after BoNT/A injction into EDB.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Difference in Force From Day 14 to Day 21 | Day 14 | 4.57 percent change from baseline | Standard Deviation 19.66 |
| Botulinum Toxin Type A, 20 Units | Difference in Force From Day 14 to Day 21 | Day 21 | 27.01 percent change from baseline | Standard Deviation 27.44 |
| Botulinum Toxin, Type A, 2 Units | Difference in Force From Day 14 to Day 21 | Day 14 | -4.81 percent change from baseline | Standard Deviation 20.94 |
| Botulinum Toxin, Type A, 2 Units | Difference in Force From Day 14 to Day 21 | Day 21 | -19.58 percent change from baseline | Standard Deviation 41.04 |
| Placebo | Difference in Force From Day 14 to Day 21 | Day 14 | 22.66 percent change from baseline | Standard Deviation 32.22 |
| Placebo | Difference in Force From Day 14 to Day 21 | Day 21 | 15.15 percent change from baseline | Standard Deviation 32.15 |
Comparison: Repeated measure ANOVA assessing percent change (from baseline) in force for contrast of day 14 and day 21 H0: There is no difference in percent change in force between day 14 and day 21 HA: There is a difference in percent change in force between day 14 and day 21p-value: 0.995Repeated measure ANOVA
Comparison: Repeated measure ANOVA assessing percent change in force from baseline for day 14 and 21 by treatment arm.~H0: There is no significant different in percent change in force by treatment arm HA: There is a significant different in percent change in force by treatment armp-value: 0.2088Repeated measure ANOVA
Secondary
Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin)
Time frame: At each visit for nerve conduction studies following injection of onabotulinumtoxinA (botulinum type A neurotoxin) into EDB (Day 0; Day 4; Day 14; Month 4)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A, 20 Units | Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin) | 0 participants |
| Botulinum Toxin, Type A, 2 Units | Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin) | 0 participants |
| Placebo | Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin) | 0 participants |
Secondary
Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB.
Measure the percent change of the Surface Electromyogram (SEMG) as measured by the Mean Rectified Voltage (MRV) with a window of 500 ms from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A or placebo. Each MRV represents the mean of 3 individual measurements of the MRV at that timepoint with measurements at least 60 seconds apart. In order to facilitate comparison from one subject to the next, the MRV is then converted into percent change from baseline for that subject.
Time frame: Baseline (mean of 3 measurement on the same day of testing) then following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Day 14 | -50.8 percent change from baseline | Standard Deviation 27.4 |
| Botulinum Toxin Type A, 20 Units | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Day 4 | -40.4 percent change from baseline | Standard Deviation 20 |
| Botulinum Toxin Type A, 20 Units | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Month 4 | -39.2 percent change from baseline | Standard Deviation 9.4 |
| Botulinum Toxin, Type A, 2 Units | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Day 14 | -52.2 percent change from baseline | Standard Deviation 14.6 |
| Botulinum Toxin, Type A, 2 Units | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Day 4 | -44.4 percent change from baseline | Standard Deviation 7.6 |
| Botulinum Toxin, Type A, 2 Units | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Month 4 | -19.8 percent change from baseline | Standard Deviation 25 |
| Placebo | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Day 4 | -4.1 percent change from baseline | Standard Deviation 69.6 |
| Placebo | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Month 4 | -28.6 percent change from baseline | Standard Deviation 56.4 |
| Placebo | Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB. | Day 14 | 0.7 percent change from baseline | Standard Deviation 38.2 |
Secondary
Stability of Baseline Measurements of Force
The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge on three different days prior to injection of BoNT/A or placebo. On each of the three days of baseline testing, the force was defined as the mean of three different measurements, separated by at least 1 minute from another measurement.
Time frame: Baseline 1 (mean of 3 measurement on the same day of testing) compared with Baseline 2 (mean of 3 measurement on the same day of testing) on a second day compared with Baseline 3 (mean of 3 measurement on the same day of testing)
Population: Normal controls at baseline before BoNT/A injected
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A, 20 Units | Stability of Baseline Measurements of Force | Baseline 2 | 7.58 kg | Standard Deviation 3.38 |
| Botulinum Toxin Type A, 20 Units | Stability of Baseline Measurements of Force | Baseline 1 | 7.78 kg | Standard Deviation 4.29 |
| Botulinum Toxin Type A, 20 Units | Stability of Baseline Measurements of Force | Baseline 3 | 7.51 kg | Standard Deviation 2.47 |
| Botulinum Toxin, Type A, 2 Units | Stability of Baseline Measurements of Force | Baseline 2 | 5.28 kg | Standard Deviation 1.81 |
| Botulinum Toxin, Type A, 2 Units | Stability of Baseline Measurements of Force | Baseline 1 | 4.83 kg | Standard Deviation 1.21 |
| Botulinum Toxin, Type A, 2 Units | Stability of Baseline Measurements of Force | Baseline 3 | 5.35 kg | Standard Deviation 1.7 |
| Placebo | Stability of Baseline Measurements of Force | Baseline 1 | 11.15 kg | Standard Deviation 5.28 |
| Placebo | Stability of Baseline Measurements of Force | Baseline 3 | 10.32 kg | Standard Deviation 5.46 |
| Placebo | Stability of Baseline Measurements of Force | Baseline 2 | 9.82 kg | Standard Deviation 5.29 |
Comparison: Repeated measure ANOVA assessing change in the three baseline force measurements H0: There no significant difference in the three baseline force measurements HA: There is a significant difference in the three baseline force measurementsp-value: 0.636Repeated measure ANOVA
Comparison: Repeated measure ANOVA assessing change in baseline force by treatment arm. H0: There is no difference in mean baseline force by treatment arm HA: There is a difference in mean baseline force by treatment armp-value: 0.178Repeated measure ANOVA